Ribociclib vs. Palbociclib in Patients With Advanced Breast Cancer Within the HER2-Enriched Intrinsic Subtype

Conditions

• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ribociclib + Letrozole OR Fulvestrant — DRUG
  Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
• Palbociclib + Letrozole OR Fulvestrant — DRUG
  Endocrine Therapy will be selected by the investigator. For premenopausal women and men: LHRH agonist once every 4 weeks
• Paclitaxel +/- Tislelizumab — DRUG
  Patients in this arm could receive as the first line of therapy

Study Details

HARMONIA is an international, multicenter, randomized, open-label and phase III study. The primary objective of this study is to demonstrate that the combination of ribociclib with endocrine therapy (letrozole or fulvestrant) is superior to palbociclib with endocrine therapy (letrozole or fulvestrant) in prolonging progression-free survival in patients with advanced HR+/HER2- and HER2-E breast cancer. The study will enroll approximately 456 patients with HER2-E disease from approximately 95 sites worldwide. In addition, the HARMONIA trial will include an exploratory cohort of patients with HR+/HER2- and Basal-like disease treated with paclitaxel +/- Tislelizumab. This cohort does not have a predefined sample size and the objective is only exploratory, given the suggested lack of efficacy of the combinations of hormone therapy and CDK4/6 inhibitors in this subgroup of patients. Enrolment into the basal-like cohort will stop once the HER2-E disease cohort is fully enrolled.

Key Dates

Start date

Mar 28, 2022

Status verified

Apr 2025

Primary completion

Mar 1, 2026

Completion

Mar 1, 2027

Study Design

Enrollment

456 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ribociclib + Endocrine Therapy
  Ribociclib + Fulvestrant or Letrozole
• Experimental: Palbociclib + Endocrine Therapy
  Palbociclib + Fulvestrant or Letrozole
• Experimental: Paclitaxel +/- Tislelizumab - Exploratory cohort
  Additional experimental Cohort that includes patients with Basal-Like intrinsic subtype.

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of randomization until the date of first documented progression, death, lost of follow-up, withdraw consent or the study is terminated by SOLTI, whichever occurs first, assessed up to approximately 62 months after the first patient enrolled ]

Locations (26)

Find similar trials in Clearwater, FL

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